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US12427295B2 - Catheter flush device, system, and methods - Google Patents

Catheter flush device, system, and methods

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Publication number
US12427295B2
US12427295B2 US16/741,998 US202016741998A US12427295B2 US 12427295 B2 US12427295 B2 US 12427295B2 US 202016741998 A US202016741998 A US 202016741998A US 12427295 B2 US12427295 B2 US 12427295B2
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US
United States
Prior art keywords
conduit
pump
housing
fluid
fluid reservoir
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active, expires
Application number
US16/741,998
Other languages
English (en)
Other versions
US20200246603A1 (en
Inventor
S. Ray Isaacson
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Becton Dickinson and Co
Original Assignee
Becton Dickinson and Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Becton Dickinson and Co filed Critical Becton Dickinson and Co
Assigned to BECTON, DICKINSON AND COMPANY reassignment BECTON, DICKINSON AND COMPANY ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ISAACSON, S. RAY
Priority to US16/741,998 priority Critical patent/US12427295B2/en
Priority to CA3126680A priority patent/CA3126680C/en
Priority to SG11202107224TA priority patent/SG11202107224TA/en
Priority to KR1020217027250A priority patent/KR102834141B1/ko
Priority to MYPI2021004042A priority patent/MY209723A/en
Priority to NZ777854A priority patent/NZ777854A/en
Priority to BR112021013291-0A priority patent/BR112021013291B1/pt
Priority to PCT/US2020/013909 priority patent/WO2020159718A1/en
Priority to AU2020216084A priority patent/AU2020216084B2/en
Priority to EP20704761.4A priority patent/EP3917594A1/en
Priority to JP2021544873A priority patent/JP7466554B2/ja
Priority to MX2021008162A priority patent/MX2021008162A/es
Publication of US20200246603A1 publication Critical patent/US20200246603A1/en
Publication of US12427295B2 publication Critical patent/US12427295B2/en
Application granted granted Critical
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Adjusted expiration legal-status Critical

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    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
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    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16831Monitoring, detecting, signalling or eliminating infusion flow anomalies
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    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M2005/1401Functional features
    • A61M2005/1403Flushing or purging
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    • A61M2025/0019Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement
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    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M2039/0009Assemblies therefor designed for particular applications, e.g. contrast or saline injection, suction or irrigation
    • A61M2039/0018Assemblies therefor designed for particular applications, e.g. contrast or saline injection, suction or irrigation designed for flushing a line, e.g. by a by-pass
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    • A61M39/02Access sites
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    • A61M2039/027Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body having a particular valve, seal or septum
    • AHUMAN NECESSITIES
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    • A61M39/10Tube connectors; Tube couplings
    • A61M2039/1072Tube connectors; Tube couplings with a septum present in the connector
    • AHUMAN NECESSITIES
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    • A61M2205/3331Pressure; Flow
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    • A61M2209/088Supports for equipment on the body

Definitions

  • vascular access device Infusion therapy, a common healthcare procedure, may be facilitated by a vascular access device. Hospitalized, home care, and other patients receive fluids, pharmaceuticals, and blood products via a vascular access device inserted into the vascular system. Blood withdrawal is another common healthcare procedure that may be facilitated by a vascular access device.
  • a vascular access device may access a peripheral or central vasculature of a patient.
  • a vascular access device may be indwelling for short term (days), moderate term (weeks), or long term (months to years).
  • a vascular access device may be used for continuous infusion therapy or for periodic infusion therapy.
  • a common type of vascular access device is a catheter, such as, for example, a peripheral intravenous catheter (PIVC) or a peripherally inserted central catheter (PICC).
  • PIVC peripheral intravenous catheter
  • PICC peripherally inserted central catheter
  • thrombolytic agent may be used to break up the occlusion in the catheter.
  • the thrombolytic agent is often expensive and installation of the thrombolytic agent may interrupt infusion therapy through the catheter. Further, risk of occlusion of the catheter may lead to increased manual flushing, which may result in an increased risk of infection.
  • a flush device may facilitate automatic flushing of a catheter to reduce or eliminate occlusion of the catheter.
  • the flush device may be portable and configured to facilitate performance of multiple tasks by a clinician.
  • the flush device may facilitate one or more of the following: manual flushing of the catheter, connection to an IV line, and blood collection.
  • the flush device may include a housing. In some embodiments, the flush device may include a proximal connector coupled to the housing and/or a distal connector coupled to the housing. In some embodiments, the flush device may include a first conduit disposed within the housing and extending between the proximal connector and the distal connector. In some embodiments, the flush device may include a second conduit disposed within the housing and in fluid communication with the first conduit.
  • the flush device may include a fluid reservoir disposed within the housing.
  • the fluid reservoir may be external to the housing.
  • the second conduit may extend between the first conduit and the reservoir.
  • the flush device may include a pump disposed within the housing.
  • the pump may be configured to pump fluid from the fluid reservoir, through the second conduit, and into the first conduit.
  • the flush device may include a one-way valve disposed within the second conduit.
  • the one-way valve may be configured to prevent fluid from flowing beyond the one-way valve toward the fluid reservoir.
  • the flush device may include a container.
  • the fluid reservoir may be disposed within the container.
  • the container may be removably disposed within the housing.
  • the container may be removed from the housing or installed into the housing by a clinician.
  • the fluid reservoir may include a vial, which may contain a fluid, such as, for example, saline.
  • the vial may hold about 5 mL of the fluid. In some embodiments, the vial may hold more than 5 mL or less than 5 mL of the fluid.
  • the pump may include an electric pump, which may provide a fluid flow rate of about 0.2 mL/hr.
  • the pump may facilitate continuous or periodic flushing of the catheter, which may prevent occlusion.
  • the pump may facilitate continuous flushing of the catheter during activation of the pump.
  • a method may include coupling a vascular access device to the flush device and activating the pump of the flush device to provide fluid from the fluid reservoir to the first conduit.
  • the fluid may be pumped from the fluid reservoir to the second conduit.
  • the fluid may flow distally through the first conduit and into the vascular access device.
  • the fluid reservoir may be depleted.
  • the method may include replacing the fluid reservoir with another fluid reservoir after deactivating the pump.
  • replacing the fluid reservoir with the other fluid reservoir may include decoupling the fluid reservoir from the second conduit, and coupling the other fluid reservoir to the second conduit.
  • the fluid reservoir may contain less fluid compared to the other fluid reservoir.
  • the method may include activating the pump, which may be performed in response to replacement of the fluid reservoir with the other fluid reservoir.
  • the other reservoir may include another container, such as, for example, a vial.
  • the flush device may not be removed from the patient (for example, the clothing article or arm band may remain secured to the patient) in between one or more of the following: infusing fluid to the patient via the pump, coupling the IV line to the proximal connector, coupling the blood collection device to the proximal connector, and coupling the syringe to the proximal connector.
  • a method of aspirating blood from the patient may include coupling the vascular access device to the flush device, deactivating the pump, coupling a blood collection device to the proximal connector, and extracting a blood sample through the proximal connector into the blood collection device.
  • the method of aspirating blood from the patient may include coupling a syringe to the proximal connector of the flush device and manually flushing the first conduit via the syringe.
  • the syringe in response to extracting the blood sample through the proximal connector into the blood collection device and uncoupling the blood collection device from the proximal connector, the syringe may be coupled to the proximal connector and the first conduit may be manually flushed.
  • FIG. 1 is an upper perspective view of an example flush device, according to some embodiments.
  • FIG. 2 A is a cross-sectional view of the flush device of FIG. 1 , illustrating an example first conduit, an example second conduit in fluid communication with the first conduit, and an example pump according to some embodiments;
  • FIG. 2 C is an enlarged view of the pump of FIG. 2 B , according to some embodiments.
  • FIG. 3 A is an upper perspective view of an example catheter system that includes the flush device of FIG. 1 , according to some embodiments;
  • FIG. 3 B is an upper perspective view of the flush device of FIG. 1 coupled to a an example clothing article worn by a patient, according to some embodiments;
  • FIG. 4 A is an upper perspective view of the flush device of FIG. 1 coupled to an example intravenous (IV) line, according to some embodiments;
  • IV intravenous
  • FIG. 4 B is an upper perspective view of the flush device of FIG. 1 coupled to an example syringe, according to some embodiments;
  • FIG. 4 C is an upper perspective view of the flush device of FIG. 1 coupled to an example blood collection device, according to some embodiments;
  • FIG. 4 D is an upper perspective view of the flush device of FIG. 1 , illustrating an example cap coupled to an example proximal connector, according to some embodiments;
  • the flush device 10 may include a fluid reservoir 18 , which may be disposed within a container 20 .
  • the container 20 may include a vial, syringe, or another suitable container.
  • the flush device 10 may include a pump disposed within the housing 12 .
  • the pump 30 may include a solenoid valve that may be activated by the pump 30 to allow fluid to flow through the second conduit 28 .
  • the solenoid valve may be maintained in a closed position when a magnetic solenoid is not energized. In some embodiments, when the magnetic solenoid is energized, the solenoid valve may open allowing fluid to flow from the fluid reservoir 18 through the second conduit 28 .
  • the flush device 10 may include a one-way valve 32 disposed within the second conduit 28 .
  • the one-way valve 32 may be configured to prevent fluid from flowing beyond the one-way valve 32 and toward the fluid reservoir 18 .
  • the one-way valve 32 may include a check valve.
  • the one-way valve 32 may prevent fluid, such as, for example, medication or blood, from entering into the pump 30 and/or the fluid reservoir 18 .
  • the vascular access device 42 may include a catheter adapter 43 .
  • the catheter adapter 43 may include a proximal end, a distal end, and a lumen extending therebetween.
  • the catheter adapter 43 may include a catheter 44 extending from the distal end.
  • the catheter 44 may include a PIVC or a PICC.
  • the distal connector 16 may be integrally formed with the housing 12 .
  • the distal connector 16 may include a luer adapter, such as a slip or thread male or female luer adapter, or another suitable connector.
  • a proximal end of the extension tube 47 may be integrally formed with the distal connector 16 .
  • the flush device 10 may be coupled to a clothing article 45 configured to be worn by a patient.
  • the housing 12 may be coupled to the clothing article 45 via threads, snaps, adhesive, or any other suitable coupling mechanism.
  • the clothing article 45 may secure the housing 12 to the patient.
  • the clothing article 45 may be an armband that may be secured to the arm of a person, as illustrated, for example, in FIG. 3 B .
  • the clothing article 45 may include a gown, a wrap, or another suitable clothing article.
  • the catheter system 41 may not include the clothing article 45 .
  • the proximal connector 14 may be configured to couple to an intravenous (IV) line 46 .
  • IV line 46 fluid from the IV line 46 may pass through the first conduit 26 and into the vascular access device 42 .
  • the proximal connector 14 may be coupled to one or more alternate fluid sources as required by an operator of the flush device 10 .
  • the proximal connector 14 may include a needleless connector or another suitable connector.
  • the proximal connector 14 may be configured to couple to a fluid supply, such as the IV line 46 .
  • a syringe 48 may be coupled to the proximal connector 14 of the device.
  • the syringe 48 may contain fluid, such as, for example, medicine to administer to the patient through the flush device 10 or saline to flush the flush device 10 and/or the vascular access device 42 .
  • the one-way valve 32 illustrated, for example, in FIGS.
  • the pump 30 may facilitate flushing of the flushing device 10 and/or the vascular access device 42 at multiple fluid flow rates.
  • manual activation of the syringe 48 may facilitate flushing at a first fluid flow rate and activation of the pump 30 may facilitate flushing at a second fluid flow rate.
  • a blood collection device 50 may be coupled to the proximal connector 14 .
  • a blood sample contained in the blood collection device 50 may be collected from the vascular access device 42 coupled to the flush device 10 .
  • the blood sample may be drawn proximally through the first conduit 26 and out of the proximal connector 14 into the blood collection device 50 coupled to the proximal connector 14 .
  • the pump 30 may be deactivated prior to collection of the blood sample.
  • the clinician may uncouple the blood collection device 50 from the proximal connector 14 and couple the syringe 48 to the proximal connector 14 .
  • the syringe 48 may be used to manually flush the first conduit 26 and/or the vascular access device 42 .
  • the one-way valve 32 may prevent blood from entering one or more of the following: the second conduit 28 , the pump 30 , and the fluid reservoir 18 .
  • the proximal connector 14 and/or the distal connector 16 may each include a cap 52 , which may be removable.
  • the cap 52 may be coupled to the proximal connector 14 and/or the distal connector 16 via threads or another suitable method.
  • installing the cap 52 on the proximal connector 14 and/or the distal connector 16 may facilitate protection of the flush device 10 from contaminants and inadvertent use.
  • the proximal connector 14 may include a septum 88 , which may prevent fluid from exiting the flush device 10 .
  • the proximal connector 14 may be integrally formed with the housing 12 .
  • the proximal connector 14 may be monolithically formed with the housing 12 as a single unit.
  • the first conduit 26 may include tubing 90 , which may be integrated with the proximal connector 14 .

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pulmonology (AREA)
  • Vascular Medicine (AREA)
  • Biophysics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
US16/741,998 2019-01-31 2020-01-14 Catheter flush device, system, and methods Active 2042-12-20 US12427295B2 (en)

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US16/741,998 US12427295B2 (en) 2019-01-31 2020-01-14 Catheter flush device, system, and methods
BR112021013291-0A BR112021013291B1 (pt) 2019-01-31 2020-01-16 Dispositivo médico
AU2020216084A AU2020216084B2 (en) 2019-01-31 2020-01-16 Catheter flush device, system, and methods
KR1020217027250A KR102834141B1 (ko) 2019-01-31 2020-01-16 카테터 플러싱 장치, 시스템 및 방법
MYPI2021004042A MY209723A (en) 2019-01-31 2020-01-16 Catheter flush device, system, and methods
NZ777854A NZ777854A (en) 2019-01-31 2020-01-16 Catheter flush device, system, and methods
CA3126680A CA3126680C (en) 2019-01-31 2020-01-16 Catheter flush device, system, and methods
PCT/US2020/013909 WO2020159718A1 (en) 2019-01-31 2020-01-16 Catheter flush device, system, and methods
SG11202107224TA SG11202107224TA (en) 2019-01-31 2020-01-16 Catheter flush device, system, and methods
EP20704761.4A EP3917594A1 (en) 2019-01-31 2020-01-16 Catheter flush device, system, and methods
JP2021544873A JP7466554B2 (ja) 2019-01-31 2020-01-16 カテーテルフラッシュ装置、システム及び方法
MX2021008162A MX2021008162A (es) 2019-01-31 2020-01-16 Dispositivo, sistema y metodos de limpieza de cateter.

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US12427295B2 (en) 2019-01-31 2025-09-30 Becton, Dickinson And Company Catheter flush device, system, and methods
US20240024620A1 (en) * 2020-08-19 2024-01-25 Hollister Incorporated Smart meter for catheter hydration and insertion
WO2025034442A1 (en) * 2023-08-04 2025-02-13 Becton, Dickinson And Company Apparatus and method for targeted delivery of thrombolytic agent to an indwelling iv catheter tip

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AU2020216084A1 (en) 2021-07-29
CN212466803U (zh) 2021-02-05
WO2020159718A1 (en) 2020-08-06
US20200246603A1 (en) 2020-08-06
JP7466554B2 (ja) 2024-04-15
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EP3917594A1 (en) 2021-12-08
CA3126680C (en) 2024-05-28
KR20210121152A (ko) 2021-10-07
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